Atopic EczemaSTARNCT03143504
A Longitudinal Investigation of Skin Barrier Development From Birth and the Validation of Early Predictors of Atopic Eczema Risk: the Skin Testing for Atopic Eczema Risk (STAR) Study
An observational study of Atopic Eczema, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons unknown. Currently the best indicator that a baby will suffer from eczema is if either or both parents have the condition, although this is not always the case. Read more about this study
- Who is it for?
- Ages 37 weeks to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- Skin Testing for Atopic eczema
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2017to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old
Who may be able to join
- Mothers 1) ≥18 years old 2) Carrying singleton pregnancies that are booked in to give birth at The Jessop maternity wing (Sheffield Teaching Hospitals NHS Foundation Trust) 3) Live within a 5 mile radius of The University of Sheffield
- Babies:
- 4) Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old
Who cannot join
- Mothers:
- <18 years old
- Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
- Unable to satisfactory give informed consent for participation
- Multiple pregnancies
- Live greater than 5 miles from The University of Sheffield
Show all 13Show fewer
- Babies:
- Admission to neonatal unit
- Major congenital malformations or limb defects
- Illness, social issues or logistical reason that at the discretion of the direct care team, will prevent comfortable trial participation by the family
- The baby is to be adopted
- Currently participating in an interventional clinical trial that interferes with the STAR study objectives
- >72 hours old -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 SJF
About this study
Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons unknown. Currently the best indicator that a baby will suffer from eczema is if either or both parents have the condition, although this is not always the case. The goal of this study is to find out if, from birth, the skin of babies who later go on to suffer from eczema develops differently to those who do not. By doing this the research team hope to detect early signs of the disease within the first year of life. Our researchers will ask 150 families from the local Sheffield community to take part in a 1-year study.
To monitor baby skin development, the investigators will carry out 3 simple procedures at the skin surface that pose no risk to the baby. These procedures will be performed on the arm and thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask parents to answer questionnaires and fill out diaries at specific time points throughout the year, to collect information on how they care for their baby's skin. By recording which babies go on to, and do not, develop eczema the investigators hope to: (1) better understand baby skin development from birth, (2) identify if these simple procedures can predict the development of eczema during the first 12 months of life, and (3) investigate environmental effects that may cause disease onset. In a medical era where the prevention of eczema is the long-term goal, it is hoped that this study will provide a new way to identify babies that may go on to develop eczema. This will allow healthcare professionals to offer specific skin care advice from birth, and empower parents to take measured action to help prevent the emergence of eczema in their baby.
Read the detailed description
The primary aim of this study is to investigate the relationship between skin barrier structure/function and skin health in a longitudinal birth cohort. The study (including the purpose and design) has been externally reviewed by a group of peers and was awarded funding by the Leo Foundation.
There is no therapeutic intervention and we will offer no healthcare advice. All participants will be instructed to seek medical care as needed from their normal service provider. As such there are no significant ethical implications.
This study involves a series of harmless procedures to test the properties of the skin in babies and the collection of information on how parents care for their baby's skin over the first 12 months of life. All types of procedures to test the skin are non-invasive and have been used safely in previous clinical studies in babies. Whilst FTIR spectroscopy was used in a previous study conducted by our team in babies (the OBSeRvE study), the investigators will now use a different FTIR instrument. Compared to the benchtop device used for OBSeRvE, the new instrument is better adapted to remote use because of its portability, is safer to use because the measurement head is made of rugged inert materials (diamond and stainless steel) compared to a fragile loop, and the detector is electrically cooled by batteries instead of liquid nitrogen. This device has been tested in humans for safety.
The approach to recruitment of study participants has been informed by the experience of several other clinical studies in babies, including the Barrier Enhancement Eczema Prevention Trial, for which Sheffield has just recently finished recruiting 250 babies. Study recruitment and the skin procedures performed shortly after birth will be led by an experienced Sheffield Teaching Hospitals Research Midwife who is familiar in this clinical environment, and is comfortable with the ethical implications of working with babies and new mothers in the early stages following birth. The Research Midwife will perform the study duties, while remaining sensitive to the needs of the women and babies on the postnatal ward (for example allowing women to breastfeed in peace if requested), and ensuring throughout that maternity service provision will not be adversely affected. The Research Midwife is fully trained in good clinical practice and informed consent. Babies will only be included in the study if the mother's consent is freely provided. Every effort will be made to minimise the burden placed on parents: this means that the researchers will go to the participants to undertake the tests, either at the hospital or at their homes.The researchers will also distribute vouchers to the participants as a "thank you" for their involvement in the study. The voucher amount will be proportionate for their involvement, and is at an appropriate level for the burden of taking part. Taking part is entirely voluntary and the researchers will observe the customs/wishes of the participants. An experienced Research Midwife will lead all hospital assessments, with subsequent follow-up visits being lead by skilled University of Sheffield employed Skin Research Technicians who hold a Sheffield Teaching Hospitals research passport and have undergone a full Disclosure and Barring Services check. All participants will be notified prior to discharge from the maternity ward that the study team conducting home visits consists of both male and female members. If the participant is not happy for a male researcher to conduct a home visit, the researchers will ensure a female member of the team is available as a replacement.
This study includes skin assessments at the participant's home. The research team will complete a lone worker risk assessment and will comply with The University of Sheffield and Sheffield Teaching Hospitals NHS Trust Lone Working guidance. The researchers will issue a study mobile phone for communication during lone working episodes. The researchers have established a set of inclusion and exclusion criteria to ensure that the study is conducted fairly. To ensure that the results are generalizable the researchers have kept the exclusion criteria to a minimum with a geographical restriction centred on the Jessops Wing Maternity Unit established simply for logistical reasons (follow-up sessions being conducted at the participant's homes). The participants will be advised that their data will be held securely, identified only by a unique study number, and that all personal information will be kept strictly confidential. Identifying personal details will be kept only on the study registration form and the Consent form. These documents provide the only link between personal information and the study participant number, and will be kept separately from study data, and stored securely in the STAR study office. Pseudonyms will be used for purposes of transcription and verbatim quotation within any publication. Audio recordings will be destroyed after transcription analysis.
- Conditions
- Atopic Eczema
- Being tested
- Skin Testing for Atopic eczema
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Testing for Atopic eczemaDiagnostic test
FTIR Spectroscopy. This will involve placing the assessment tool briefly in contact with the baby's skin on the arm and thigh.
Transepidermal Water Loss. This will involve placing a probe on the baby's skin for approximately 60 seconds on the arm and thigh. The probe measures the rate of water loss from the baby's skin, which indicates how well it acts as a barrier.
Collection of skin samples. This will involve collecting surface skin samples using small sticky-tape discs to collect only the very top skin cells that are already dead and about to be shed naturally by the body.
Microbial swab. The researchers will rub the baby's skin gently with a wet sterile swab to collect a sample of the microbes on the baby's skin surface.
Buccal swab / saliva sample. The researchers will collect a sample of the baby's saliva using a buccal swab. This sample will be used to analyse the baby's genes (DNA) to assess their inherited risk of eczema.
| Study group | Role | What they receive |
|---|---|---|
| Single arm. | All participants in the same arm. Receives: Diagnostic Test: Skin Testing for Atopic eczema |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Changes in the molecular structure of the skin from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by in-vivo ATR-FTIR spectroscopy
As above
Measured: at 4 weeks (+2 weeks), and at 12 months of age (± 1
Changes in skin barrier function from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
As above
Measured: from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
Changes in desquamatory protease activity (nU μg-1) from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age determined by ex-vivo laboratory assay.
As above
Measured: (≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months
Secondary outcomes (6)
Incidence of eczema (UK working party diagnosis) and 'skin rashes' (self-reported) in study participants by 12 months of age.
As above
Measured: 12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at birth (≤72 hours old) to predict onset of eczema by 12 months of age using mixed model regression analysis.
As above
Measured: 12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
As above
Measured: measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Incidence of filaggrin loss-of-function mutations within the study population determined by DNA genotyping, and its relationship with skin barrier development / eczema risk by 12 months of age
As above
Measured: 12 months
Capture of information through participant diaries and questionnaires to determine the interaction between the home environment and how parents care for their baby's skin in relation to skin barrier development / eczema risk by 12 months of age.
As above
Measured: 12 months
Capture of parental satisfaction through participant questionnaires on (i) the potential for early diagnosis of skin conditions, (ii) skin care treatments, and (iii) the skin assessments used by this study
As above
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start2 Mar 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Simon G Danby, PhD, BSc, Study director, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143504
- Sponsor's protocol ID
- STH19479
- Acronym
- STAR
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chittock J, Kay L, Brown K, Cooke A, Lavender T, Cork MJ, Danby SG. Association between skin barrier development and early-onset atopic dermatitis: A longitudinal birth cohort study. J Allergy Clin Immunol. 2024 Mar;153(3):732-741.e8. doi: 10.1016/j.jaci.2023.10.017. Epub 2023 Nov 4.
PubMed 37926123
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Investigation of Skin Barrier Development From Birth and the Validation of Early Predictors of Atopic Eczema Risk: the Skin Testing for Atopic Eczema Risk (STAR) Study
- ClinicalTrials.gov ID
- NCT03143504
- Acronym / sponsor ID
- STAR / STH19479
- Conditions
- Atopic Eczema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons unknown. Currently the best indicator that a baby will suffer from eczema is if either or both parents have the condition, although this is not always the case. The goal of this study is to find out if, from birth, the skin of babies who later go on to suffer from eczema develops differently to those who do not. By doing this the research team hope to detect early signs of the disease within the first year of life. Our researchers will ask 150 families from the local Sheffield community to take part in a 1-year study.
To monitor baby skin development, the investigators will carry out 3 simple procedures at the skin surface that pose no risk to the baby. These procedures will be performed on the arm and thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask parents to answer questionnaires and fill out diaries at specific time points throughout the year, to collect information on how they care for their baby's skin. By recording which babies go on to, and do not, develop eczema the investigators hope to: (1) better understand baby skin development from birth, (2) identify if these simple procedures can predict the development of eczema during the first 12 months of life, and (3) investigate environmental effects that may cause disease onset. In a medical era where the prevention of eczema is the long-term goal, it is hoped that this study will provide a new way to identify babies that may go on to develop eczema. This will allow healthcare professionals to offer specific skin care advice from birth, and empower parents to take measured action to help prevent the emergence of eczema in their baby.
Detailed description
The primary aim of this study is to investigate the relationship between skin barrier structure/function and skin health in a longitudinal birth cohort. The study (including the purpose and design) has been externally reviewed by a group of peers and was awarded funding by the Leo Foundation.
There is no therapeutic intervention and we will offer no healthcare advice. All participants will be instructed to seek medical care as needed from their normal service provider. As such there are no significant ethical implications.
This study involves a series of harmless procedures to test the properties of the skin in babies and the collection of information on how parents care for their baby's skin over the first 12 months of life. All types of procedures to test the skin are non-invasive and have been used safely in previous clinical studies in babies. Whilst FTIR spectroscopy was used in a previous study conducted by our team in babies (the OBSeRvE study), the investigators will now use a different FTIR instrument. Compared to the benchtop device used for OBSeRvE, the new instrument is better adapted to remote use because of its portability, is safer to use because the measurement head is made of rugged inert materials (diamond and stainless steel) compared to a fragile loop, and the detector is electrically cooled by batteries instead of liquid nitrogen. This device has been tested in humans for safety.
The approach to recruitment of study participants has been informed by the experience of several other clinical studies in babies, including the Barrier Enhancement Eczema Prevention Trial, for which Sheffield has just recently finished recruiting 250 babies. Study recruitment and the skin procedures performed shortly after birth will be led by an experienced Sheffield Teaching Hospitals Research Midwife who is familiar in this clinical environment, and is comfortable with the ethical implications of working with babies and new mothers in the early stages following birth. The Research Midwife will perform the study duties, while remaining sensitive to the needs of the women and babies on the postnatal ward (for example allowing women to breastfeed in peace if requested), and ensuring throughout that maternity service provision will not be adversely affected. The Research Midwife is fully trained in good clinical practice and informed consent. Babies will only be included in the study if the mother's consent is freely provided. Every effort will be made to minimise the burden placed on parents: this means that the researchers will go to the participants to undertake the tests, either at the hospital or at their homes.The researchers will also distribute vouchers to the participants as a "thank you" for their involvement in the study. The voucher amount will be proportionate for their involvement, and is at an appropriate level for the burden of taking part. Taking part is entirely voluntary and the researchers will observe the customs/wishes of the participants. An experienced Research Midwife will lead all hospital assessments, with subsequent follow-up visits being lead by skilled University of Sheffield employed Skin Research Technicians who hold a Sheffield Teaching Hospitals research passport and have undergone a full Disclosure and Barring Services check. All participants will be notified prior to discharge from the maternity ward that the study team conducting home visits consists of both male and female members. If the participant is not happy for a male researcher to conduct a home visit, the researchers will ensure a female member of the team is available as a replacement.
This study includes skin assessments at the participant's home. The research team will complete a lone worker risk assessment and will comply with The University of Sheffield and Sheffield Teaching Hospitals NHS Trust Lone Working guidance. The researchers will issue a study mobile phone for communication during lone working episodes. The researchers have established a set of inclusion and exclusion criteria to ensure that the study is conducted fairly. To ensure that the results are generalizable the researchers have kept the exclusion criteria to a minimum with a geographical restriction centred on the Jessops Wing Maternity Unit established simply for logistical reasons (follow-up sessions being conducted at the participant's homes). The participants will be advised that their data will be held securely, identified only by a unique study number, and that all personal information will be kept strictly confidential. Identifying personal details will be kept only on the study registration form and the Consent form. These documents provide the only link between personal information and the study participant number, and will be kept separately from study data, and stored securely in the STAR study office. Pseudonyms will be used for purposes of transcription and verbatim quotation within any publication. Audio recordings will be destroyed after transcription analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm. | – | Diagnostic Test: Skin Testing for Atopic eczemaAll participants in the same arm. |
Who may qualify
- Ages
- 37 weeks to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old
Key inclusion criteria (3 listed)
- Mothers 1) ≥18 years old 2) Carrying singleton pregnancies that are booked in to give birth at The Jessop maternity wing (Sheffield Teaching Hospitals NHS Foundation Trust) 3) Live within a 5 mile radius of The University of Sheffield
- 4) Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old
Key exclusion criteria (13 listed)
- <18 years old
- Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
- Unable to satisfactory give informed consent for participation
- Multiple pregnancies
- Live greater than 5 miles from The University of Sheffield
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Testing for Atopic eczemaFTIR Spectroscopy. This will involve placing the assessment tool briefly in contact with the baby's skin on the arm and thigh. Transepidermal Water Loss. This will involve placing a probe on the baby's skin for approximately 60 seconds on the arm and thigh. The probe measures the rate of water loss from the baby's skin, which indicates how well it acts as a barrier. Collection of skin samples. This will involve collecting surface skin samples using small sticky-tape discs to collect only the very top skin cells that are already dead and about to be shed naturally by the body. Microbial swab. The researchers will rub the baby's skin gently with a wet sterile swab to collect a sample of the microbes on the baby's skin surface. Buccal swab / saliva sample. The researchers will collect a sample of the baby's saliva using a buccal swab. This sample will be used to analyse the baby's genes (DNA) to assess their inherited risk of eczema. | Diagnostic test | Single arm. |
Primary outcome
1) Changes in the molecular structure of the skin from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by in-vivo ATR-FTIR spectroscopy
Time frame: at 4 weeks (+2 weeks), and at 12 months of age (± 1
As above
Changes in skin barrier function from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
Time frame: from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
As above
Changes in desquamatory protease activity (nU μg-1) from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age determined by ex-vivo laboratory assay.
Time frame: (≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months
As above
6 secondary outcomes
Incidence of eczema (UK working party diagnosis) and 'skin rashes' (self-reported) in study participants by 12 months of age.
Time frame: 12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at birth (≤72 hours old) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Time frame: 12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Time frame: measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Incidence of filaggrin loss-of-function mutations within the study population determined by DNA genotyping, and its relationship with skin barrier development / eczema risk by 12 months of age
Time frame: 12 months
Capture of information through participant diaries and questionnaires to determine the interaction between the home environment and how parents care for their baby's skin in relation to skin barrier development / eczema risk by 12 months of age.
Time frame: 12 months
Capture of parental satisfaction through participant questionnaires on (i) the potential for early diagnosis of skin conditions, (ii) skin care treatments, and (iii) the skin assessments used by this study
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 37926123Chittock J, Kay L, Brown K, Cooke A, Lavender T, Cork MJ, Danby SG. Association between skin barrier development and early-onset atopic dermatitis: A longitudinal birth cohort study. J Allergy Clin Immunol. 2024 Mar;153(3):732-741.e8. doi: 10.1016/j.jaci.2023.10.017. Epub 2023 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon G Danby, PhD, BSc study director
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Eczema, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Changes in the molecular structure of the skin from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by in-vivo ATR-FTIR spectroscopy (time frame: at 4 weeks (+2 weeks), and at 12 months of age (± 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.